FDA Inspection 1077449 — Micro Current Technology, Inc.
The FDA completed an inspection of Micro Current Technology, Inc. on January 28, 2019 in Seattle, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 28, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |